Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer, List Number 08H00-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA.
This recall has been terminated (originally issued April 23, 2009).
- Company
- Abbott Laboratories
- Recall Initiated
- December 10, 2008
- Posted
- April 23, 2009
- Terminated
- December 27, 2010
- Recall Number
- Z-1069-2009
- Quantity
- 30 syringes
- Firm Location
- Santa Clara, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.
Distribution
Worldwide Distribution -- USA, Australia, Canada, and Germany.
Lot / Code Info
Barcode numbers Starting with SYR-S12E-, and ending with 0066, 0074, 0078, 0079, 0097, 0100, 0244, 0130, 0134, 0144, 0145, 0146, 0147, 0245, 0148, 0153, 0211, 0213, 0216, 0217, 0247, 0218, 0222, 0224, 0225, 0232, 0234, 0248, 0235, 0236, 0237, 0239, 0240, and 0243.
Root Cause
Process control
Action Taken
Recall initiated on December 10, 2008. A product recall letter and reply form were cent to CELL-DYN Sapphire customers who received syringes between September 16, 2008 and October 28, 2008 to US customers, and to November 5, 2008 for Outside-of-US customers.